Evaluation of Changes of Hard and Soft Tissues After Epi-crestal and Sub-crestal Placement of Ankylos Dental Implants.

Dentsply International1 site in 1 country48 target enrollmentApril 2012

ConditionsMouth, Edentulous

Overview

Phase: N/A
Intervention: Not specified
Conditions: Mouth, Edentulous
Sponsor: Dentsply International
Enrollment: 48
Locations: 1
Primary Endpoint: Change in Marginal Bone Level (MBL)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to test two standard of care techniques of placing dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.

Detailed Description

The purpose of this study is to test epicrestal and subcrestal placement of dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

April 2019

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dentsply International

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must have read, understood and signed an informed consent form;
•Subjects must be 18 to 70 years of age;
•Subjects must be able and willing to follow study procedures and instructions;
•Subjects must have indication to receive two implants in a bilateral maxillary or mandibular edentulous areas (for at least 4 months post extraction) in areas of pre-molars (first or second) and molars (first or second);
•Sufficient width and height of bone to place at least 8mm length and any compatible in diameter Ankylos implant;
•Sufficient vertical clearance to place a single tooth crown replacement;
•No apical disorder/inflammation at the area of the implant site.

Exclusion Criteria

•Subjects participating in other clinical studies within 1 month prior to screening and/or involving therapeutic intervention (either medical or dental) that could affect bone or soft tissue healing;
•Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study;
•Subjects with parafunctional habits;
•Subjects who have failed to maintain good plaque control;
•Subjects with any systemic condition like uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, bone metabolic diseases, radiation or other immuno-suppressive therapy which would preclude periodontal surgery;
•Absence of occlusal stability in centric occlusion;
•Subjects with the presence of acute infectious lesions in the areas intended for surgery;
•History within the last 3 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking and cigarette smoking (greater than 10 cigarettes per day)
•Present alcohol or drug abuse;
•Angulation requirements of the restoration exceeding approximately 15 degrees;

Outcomes

Primary Outcomes

Change in Marginal Bone Level (MBL)

Time Frame: Implant placement, and 18 months and 30 months after implant placement

Changes in MBLs at 18 months and 30 months after implant placement were chosen as primary outcome parameters. Results are described as mean values and standard deviations. Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as "mid-facial bone levels". To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18 and T30.

Secondary Outcomes

Change in Mid-Buccal Soft Tissue Height(From final restoration (6 months after implant placement), and 12 months, 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement)
Change of Interproximal Levels After Final Restoration(From final restoration (6 months after implant placement), and 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement)
Change in Marginal Bone Level (MBL)(Implant placement, and 66 months after implant placement)